[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8819]
[[Page Unknown]]
[Federal Register: April 13, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CDC--410]
RIN 0905-ZA39
Announcement of Cooperative Agreement to Case Western Reserve
University
Summary
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1994 funds to continue, on a sole
source basis, a Human Immunodeficiency Virus (HIV)-Related Tuberculosis
Demonstration cooperative agreement on applied drug efficacy and
preventive therapy (ADEPT) with Case Western Reserve University (CWRU).
Approximately $500,000 will be available in FY 1994 to support this
project. It is expected the award will begin on August 1, 1994, for a
12-month budget period within a 5-year project period. Funding
estimates may vary and are subject to change. Continuation awards
within the project period will be made on the basis of satisfactory
progress and availability of funds.
The purpose of this cooperative agreement is to improve the
diagnosis, prevention, and treatment of tuberculosis in persons
infected with HIV through demonstration and applied research. Applied
research, as used in the context of this announcement, means the
process of developing and evaluating practical operational approaches
and solutions to tuberculosis problems.
The CDC will (1) Provide consultation and technical assistance in
planning, implementing, and evaluating strategies and protocols, (2)
Provide up-to-date scientific information on tuberculosis and HIV-
infection and related diseases, (3) Assist in data management,
analysis, and the evaluation of programmatic activities, and (4) Assist
in the preparation and publication of results.
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of ``Healthy People
2000,'' a PHS-led national activity to reduce morbidity and mortality
and improve the quality of life. This announcement is related to the
priority areas of HIV Infection and Immunization and Infectious
Diseases. (For ordering a copy of ``Healthy People 2000,'' see the
Section WHERE TO OBTAIN ADDITIONAL INFORMATION.)
Authority
This program is authorized under sections 301(a) and 317(k)(2) of
the Public Health Service Act, [42 U.S.C. 241(a) and 247b(k)(2)], as
amended.
Smoke-Free Workplace
The Public Health Service strongly encourages all grant recipients
to provide a smoke-free workplace and promote the non-use of all
tobacco products. This is consistent with the PHS mission to protect
and advance the physical and mental health of the American people.
Eligible Applicant
Assistance will be provided only to CWRU for this project. No other
applications are solicited. The program announcement and application
kit have been sent to CWRU.
CWRU is the most appropriate and qualified agency to provide the
services specified under this cooperative agreement because:
1. In 1991, CWRU was the only applicant funded through the
competitive announcement #114, ADEPT/HIV-Related Tuberculosis
Demonstration. The study being conducted is a trial of preventive
therapy in HIV-infected persons in Uganda; regimens being followed in
the current study are novel chemotherapy regimens requiring long-term
follow up of patients to determine the efficacy of these drugs. CWRU
currently has enrolled more than 600 tuberculin-positive patients in
the study. During the initial months of recruitment, the investigators
found a significant number of immunocompromised patients unable to
respond to skin test antigens (anergic). Since October 1993, these
patients are being enrolled in the study to assess whether they are at
even higher risk for the development of tuberculosis and whether
preventive treatment would be effective. As of November 1993, 11
anergic patients were participating in the trial. Enrollment into the
study is continuing; however, there will not be sufficient time in the
current project period to complete the enrollment of 1200 nonanergic
and 500 anergic patients and follow these patients for the 2 years
necessary to collect meaningful data on the efficacy of the preventive
therapy regimens. Without continuing the project for an additional 5
years, the data collected to date will be of limited usefulness in
assessing the efficacy of the regimens evaluated in this study.
2. The work under this cooperative agreement will be conducted in
the Republic of Uganda. Uganda has one of the highest prevalences of
HIV and tuberculous dually-infected persons in the world. The CWRU
project is able to enroll 20 nonanergic and 5 anergic patients each
week; no other known sites have access to sufficient patients to enroll
at this rate. This rate of enrollment is necessary to ensure that
sufficient numbers of patients are enrolled to provide statistically-
valid results within a relatively short period of time. The CWRU
research team also has established relations with Ugandan institutions
that should ensure the success of a high-quality trial. Results on the
efficacy of preventive therapy regimens in HIV-infected persons are
needed to aid in the elimination of tuberculosis in the United States,
as outlined in ``A Strategic Plan for the Elimination of Tuberculosis
in the United States.''
3. CWRU possesses proven scientific and managerial competence in
treating TB patients and in conducting clinical research trials. Many
of the patients in the current cohort have been followed for as long as
a year with very few patients lost to follow up. CWRU has been
successful in other CDC-funded clinical trials involving the long-term
follow-up (2 years or more) of HIV-infected persons.
4. To date, CDC has provided over $1,000,000 to establish this
cohort. Use of this cohort will be less expensive and provide more
timely results than to begin enrollment of another cohort at a
different site. Additionally, no other known site can provide
enrollment at the rate necessary to adequately assess the treatment
regimens.
5. The current spread of TB demands new methods for combating this
disease. The results of this study will add significantly to the body
of information on the efficacy of specific regimens in preventing
tuberculosis in HIV-infected persons. The rifampin-containing regimens
may provide options for preventing tuberculosis in HIV-infected persons
exposed to INH-resistant organisms.
Executive Order 12372 Review
The application is not subject to review as governed by Executive
Order 12372, Intergovernmental Review of Federal Programs.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirement.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance Number is 93.947,
Tuberculosis Demonstration, Research, Public and Professional
Education; and 93.941, Human Immunodeficiency Virus (HIV)
Demonstration, Research, Public and Professional Education.
Other Requirements
Human Subjects
The applicant must comply with the Department of Health and Human
Services regulations (45 CFR part 46) regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Confidentiality
Applicant must have in place systems to insure the confidentiality
of all patient records.
Pre- and Post-test Counseling and Partner Notification
Recipient is required to provide HIV antibody testing to determine
a person's HIV infection status; therefore, they must comply with local
laws and regulations and CDC guidelines regarding pre- and post-test
counseling and partner notification of HIV-seropositive patients, a
copy of which will be included in the application kit. Recipient must
also comply with local requirements relating to specific reportable
diseases or conditions. Recipient must provide referrals for HIV
diagnosis and treatment.
Where to Obtain Additional Information
If you are interested in obtaining additional information regarding
this project, please refer to Announcement 410 and contact Manuel
Lambrinos, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
16, Atlanta, GA 30305, telephone (404) 842-6777.
A copy of ``Healthy People 2000'' (Full Report; Stock No. 017-001-
00474-0) or ``Healthy People 2000'' (Summary Report; Stock No. 017-001-
00473-1) referenced in the SUMMARY may be obtained through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325, telephone (202) 783-3238.
Dated: April 7, 1994.
Robert L. Foster,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 94-8819 Filed 4-12-94; 8:45 am]
BILLING CODE 4163-18-P